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28 ArticlesUSFDA

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Dr Reddy’s USFDA Inspection of Oncology Formulation Manufacturing Facility at Duvvada – Form 483 Revealed

Today we cover the Form 483 issued by the US FDA to Dr. Reddy’s oncology formulation manufacturing facility at Duvvada at Visakhapatnam, Andhra Pradesh. On ...
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Cadila Healthcare US FDA Inspection of Baddi – Form 483 Revealed

Today we cover the Form 483 issued by the US FDA to Cadila Healthcare’s formulations manufacturing plant at Baddi. On another note, the company is due to ...
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Dr Reddy’s Laboratories US FDA Inspection of Miryalaguda – Form 483 Revealed

Today we cover the Form 483 issued by the US FDA to Dr. Reddy’s API manufacturing plant at Miryalaguda. On another note, the company’s formulation ...
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We Reveal The Observations Made By US FDA’s Inspection Of Natco’s Kothur Facility

True to our promise of keeping a tab on the regulatory inspections of Indian Pharmaceutical companies, we are happy to get our hands on the Form 483 issued ...
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Exclusive: We Reveal The Observations Made By US FDA’s Inspection Of Granules OmniChem's Vizag Facility

True to our promise of keeping a tab on the regulatory inspections of Indian Pharmaceutical companies, we are happy to get our hands on the Form 483 issued ...
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We Reveal The Form 483 Issued By US FDAs Inspection Of Divis Laboratories Unit-II At Visakhapatnam

Here is our coverage of the Form 483 issued by the US FDA from the inspection of Divis Laboratories Unit-II located at Visakhapatnam. You can catch all our ...
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Exclusive: We Reveal The Observations Made By US FDA’s Inspection Of Sun Pharma’s Halol Facility

True to our promise of keeping a tab on the US FDAs inspection of Sun Pharma’s Halol facility, we are happy to get our hands on the Form 483 issued for ...
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Alkem Laboratories & Divis Laboratories Receive Form 483 From US FDA

With the dust yet to settle on the US FDAs inspection of Sun Pharmaceuticals Mohali, Punjab and Halol, Gujarat plants, 2 more companies have reported receiving ...
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Tracking The Sun Pharma Halol Plant US FDA Inspection

This is not a recommendation to buy or sell the stock. Analyst and family do own some of the positions listed here. Please assume we are biased. With ...
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Alkem Laboratories Recalls 1,739,000 Tablets Of Used For The Treatment Of Oral Diabetes

New Jersey, US based Ascend Laboratories has initiated a recall of Metformin Hydrochloride Tablets manufactured by Mumbai based Alkem Laboratories. The ...
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